Do CBD Products Need FDA Approval?

According to former U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, the agency’s stakeholders and the American public have recently been seeking clarification on how their oversight applies to CBD products available in the marketplace.

CBD refers to cannabidiol, a derivative of the Cannabis Sativa L. plant which is being commercially pushed and attributed with a number of therapeutic properties in numerous CBD products across the spectrum as medicine, supplements, food sources, veterinarian food and drugs, and in cosmetics.

The FDA has regulatory authority granted to it through the Federal Food Drug and Cosmetic Act (FDCA), which was passed into law in 1938. Its principal aim to ensure that the safety of the American people is maintained by keeping our food and drug supply safe. This goal also applies to devices marketed as tools to assist with health maintenance and materials applied to the body for aesthetic purposes.

How Did the Passage of the 2018 Farm Bill Affect Interest in CBD Products?

As indicated in a separate FDA article published on July 25, 2019, the 2018 Farm Bill passed in December of that same year essentially destigmatized hemp with very low amounts of psychoactive compound delta-9tetrahydrocannabinol (THC) associated with the “high” of marijuana use. Hemp products and associated compounds with less than .3 percent of this active ingredient were no longer considered controlled substances.

So not only did the law’s passage allow farmers to grow hemp falling into this category lawfully, it expanded interest in how to market products derived from crops through legal and legitimate channels. This increased public interest has put pressure on the FDA to step up and announce its place in the “game”.  According to former Commissioner Gottlieb, Congress empowered the FDA by preserving its authority over food, drugs, supplements, and cosmetics containing compounds from cannabis under the FDCA.

Have Products Containing CBD Been Marketed Illegally?

Although hemp with very low concentrations of THC is no longer a controlled substance, the FDA has a duty to protect the public from manufacturers and distributors that would make outlandish, irresponsible, and scientifically unfounded claims concerning the therapeutic value of their products. The FDA has sent out warning letters, according to Gottlieb to at least three companies for making unsubstantiated claims in their products. These companies are Advanced Spine and Pain LLC (d/b/a Relievus), Nutra Pure LLC and PotNetwork Holdings Inc. The organizations have reportedly made claims that their products can cure cancer, stop the progression of Alzheimer’s disease, assist in breaking an opiate addictive process, and effectively treat fibromyalgia.

In making these claims, the FDA states that it is concerned that people will cease to seek legitimate and approved treatments while pursuing new cannabis compound treatment with no scientific backing.

Laboratory testing of many CBD oils and gels have also found the active content to often be at odds with labeling. Consumers should be on the lookout for potential mislabeling among these products:

• Diamond CBD vape additive
• Green Machine Pods
• New World CBD
• Yolo CBD oil cartridge
• Eco Sciences
• Experience CBD Gummies
• Hawaiian Health
• Pheel Goodz
• Zilla Pods

Join a Free CBD Supplements Class Action Lawsuit Investigation

If you purchased a CBD supplement, it may have contained far less of the active ingredient that you were led to believe, and you may qualify to join this CBD supplement class action lawsuit investigation.

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This article is not legal advice. It is presented
for informational purposes only.